Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT06789718
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years old
* Has self-reported sleep disturbance
* Insomnia Severity Index (ISI) score of \> 15, with score on question on difficulty falling asleep \> 2 ("moderate") at screening
* Interested in understanding more about their sleep and choose to use the probiotic product
* Willing to do a 1-week washout out of any OTC or other products for sleep and/or (e.g. melatonin, anticholinergics, valerian root etc.) prior to randomization and refrain from use for the duration of the study
* Willing to do a 4-week washout from any systemic antibiotic, prebiotic, probiotic and postbiotic use prior to randomization
* If taking prescription medications for sleep and/or anxiety (e.g. Benzodiazepines, zolpidem, zaleplon, SSRIs, Buspirone, Tricyclics, MAOIs), or other class of medication for sleep, must be on a "stable dose" for at least 4 weeks prior to randomization. "Stable dose" is defined as no changes in dosage or frequency of the specified medications for at least 4 weeks prior to randomization and throughout the study period.
* If using any cannabis-containing products, must be on a stable dose for at least 4 weeks prior to randomization and consume \< 10 mg/day of THC
* If regularly consuming alcohol, must be willing to stay on a stable amount throughout the study period and to log alcohol consumption.
* In good general health at the time of screening (Investigator discretion).
* Able to read and understand English.
* Able to read, understand, and provide informed consent.
* Able to use a personal smartphone device and download Chloe by People Science.
* Able to receive shipment of the product at an address within the United States.
* Is willing to wear, sync daily, and charge twice weekly a provisioned health tracking wearable device (Oura ring) everyday (up to 7 weeks) during sleep. If the participant already has an Oura ring, they can use their own device and account.
* Able to complete study assessments over the course of up to 7 weeks.
Exclusion Criteria:
* Do not have a smartphone and/or internet access.
* Concomitant Therapies:
* Participants taking prescription medication for sleep and/or anxiety (e.g. Benzodiazepines, zolpidem, zaleplon, SSRIs, Buspirone, Tricyclics, MAOIs) not on a stable dose for at least 4 weeks
* Participants receiving Cognitive Behavioral Therapy for Insomnia (CBTi)
* Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
* Participants taking any other prescription medications that impact systemic GABA levels (e.g., GABA supplements, barbiturates, gabapentin, pregabalin, valproate, tiagabine, vigabatrin, baclofen)
* Participants currently taking or have taken probiotics, prebiotics or postbiotics within the past 4 weeks prior to randomization.
* Current antibiotic use or use within 4 weeks prior to randomization.
* Other Illnesses or Conditions: Participants who have the following conditions or comorbidities are excluded:
* Confirmed diagnoses of the following sleep disorders: Narcolepsy, Restless Leg Syndrome, Circadian Rhythm Disorders
* Confirmed diagnosis of Sleep Apnea that is untreated or not well controlled
* Known diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) or Irritable Bowel Syndrome
* Current or prior history of psychotic disorder
* Confirmed diagnosis of major depressive disorder or bipolar disorder
* Diagnosed with Alcohol or Substance Abuse Disorder
* Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding
* Presence of any infection or illness that causes chronic night-waking or impairs ability to retain urine overnight (e.g., chronic pain, uncontrolled benign prostatic hyperplasia, prostatitis, urinary tract infection, catheterization, etc.).
* Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the trial or impact the trial outcomes.
* Known hypersensitivity or previous allergic reaction to microcrystalline cellulose (MCC).
* Presence of another environmental factor that severely impacts sleep quality (e.g., a new baby, pet or other loved one that wakes frequently or needs frequent care or feeding throughout the night)
* Work in an environment requiring shift work (e.g., rotating shifts, night shifts, or irregular hours).
* Have any known and planned international travel during the study period.
* Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06789718
Study Brief:
Protocol Section:
NCT06789718